Two out of three Americans are overweight or obese. According to the World Health Organization, there are millions of overweight and obese adults and children around the world, raising the risk for conditions such as heart disease and diabetes. The most recent drug that succeeded widely in helping people lose weight was withdrawn from the market in 1997. Fen-phen was linked to heart valve damage, a side effect whose risk exceeded the benefits of losing weight. Since then, the two prescription drugs to fight obesity, Xenical and Meridia have been disappointing, both in terms of their effectiveness and their sales.
“Our solution, unlike the prescription drugs currently on the market, has both a proven safety record and no side effects,” says Ronit Gross, one of the founders of the holding company, Bio-Light. Gross sits in the company’s offices in the Ayalon Tower, the Tel Aviv skyline stretched before her. She is an experienced attorney in the high tech and bio tech start-up world, who decided to move over into the business side herself. Bio-Light counts OBEcure among the four companies in its portfolio.
She is able to speak so confidently of OBEcure’s safety and lack of side effects because the solution was found by an Israeli scientist, who has, essentially, not discovered a new drug, but created a new use for an old one.
In his research, Dr. Nir Barak noted that one of the receptors in the brain for histamine, called H1, caused people to gain weight when it was blocked. Antihistamines are given to counteract allergies which are caused by histamine secretions. Barak, a specialist in internal medicine and nutrition at the Rabin Medical Center in Petah Tikva observed that antihistamines which block H1 caused weight gain. He theorized that if there was some way to stimulate the receptor, it could help weight loss.
When he went looking for a drug that could do this, he was surprised to find that one was already on the market, but for a completely different purpose.
A drug to help prevent vertigo has existed for the past 40 years. In terms of the development of pharmaceuticals, this was like hitting the lottery. Since the drug has been used for years by tens of millions of people without damaging side effects, this means that its safety is already proven, and he only needed to show that it was effective in causing weight loss in order to go after the lucrative US market.
The FDA’s criteria for an anti-obesity drug to be proven effective is for it to offer a five percent weight loss on an annual basis together with diet and exercise. In a double-blind trial, he accomplished this. Twenty overweight women lost a significant amount of weight after one month on the drug.
Barak had done the research under the auspices of Mor Research Applications, the technology transfer arm of Clalit, the Israeli Health Fund that operates the Rabin Medical Center. He approached patent attorney Dr. Gal Ehrlich, to file a patent on his discovery. Ehrlich, excited by the breakthrough and aware of its commercial potential, brought it to Bio-Light, where he is a partner. In addition to Ehrlich and Gross, Bio-Light partners include CEO Dr. Ami Eyal, a specialist in general surgery, and Richard Naimer, who heads the venture capital and technology practice.
Bio-Light then licensed the rights to the technology of Barak – who now serves as ObCure’s chief scientist – with the goal of developing his work into an anti-obesity drug specifically for the US market. Why the US?
“First of all, because obesity is such a growing problem for Americans,” Gross told ISRAEL21c. Another reason is because while the anti-vertigo drug that ObCure mimics is still being marketed in other countries, in the US, it is no longer available after the FDA determined that it was not sufficiently effective against vertigo. So once they prove it successfully fights obesity, OBEcure will have exclusive license to market the drug in the US.
“Almost 100 million patients have used the drug without any significant side effect,” CEO Eyal, sitting beside Gross, interjects. “That’s a lot, there are few new pharmaceuticals that can claim that.”
Because the safety of the drug has already been proven in the general population, OBEcure has been able to take the fast track into Phase II trials, which they are planning to take place in several sites in the US in the next few months. If Phase II is successful, in all likelihood, one of the major pharmaceutical companies is likely to snap up the company. Fighting fat, after all, is big business.
A recent visit to the United States for meetings with the FDA has Eyal feeling optimistic. “The regulators were very upbeat.” And in the corporate world, “there is a considerable amount of interest in us.”
Even bigger business could result by further developing the drug. Currently, many antipsychotic and antidepressant drugs have a disturbing side effect of causing rapid weight gain. If the ingredient in OBEcure’s drug can be compounded with these pharmaceuticals, it may be a way to treat depression and bipolar disorder without causing patients to gain weight.
According to Gross, Biolight has an unusual business model in the world of startups. With the exception of OBEcure, the other three companies in its portfolio are all companies that have been ‘resurrected.’ They were startups which closed, not because their technology wasn’t promising, but because of management or strategy problems. After examining them closely, the Biolight team determined that they had the potential to succeed if given a second chance.
The three companies are Allergica, which is developing a drug to block allergic reactions, Optotech, which is developing laser-based non-invasive technology for the treatment of glaucoma, and Zetig Technologies, which is developing bedside diagnostic kits for use during surgical cancer procedures and diagnostic kits for research and development of cancer drugs.
Confidence in Bio-Light has been so high that it has gone public at a relatively early stage; the company went up on Tel Aviv Stock Exchange in December 2005, and the stock price has climbed significantly since then. The sense of anticipation is not surprising, considering the fact that this is a drug that millions are waiting for.
“Listen, the world urgently needs a drug that is safe and effective against obesity,” said Eyal. “Our compound has a very safe profile and we have enough data to show efficacy and there is more on the way. We firmly believe we will bring a solution to the overweight population.”